The Food and Drug Administration (FDA) on Wednesday sidestepped a major crackdown on companies that make popular synthetic nicotine products, drawing ire from Democrats and anti-tobacco advocates.
Synthetic nicotine is made in a lab and enabled companies to skirt FDA regulation since the agency previously did not have the ability to regulate it like it does tobacco-derived nicotine. Synthetic nicotine products are often fruity flavored and popular with young people.
But then Congress explicitly gave the agency that authority in March as part of a government spending package.
Under the law, companies had until May 14 to submit a premarket application to keep their products on the market. Any company that didn’t would be considered illegal, and would need to remove their products by July 13.
Late Wednesday, the agency said it had issued warning letters to two companies that make synthetic nicotine vaping products. According to the agency, AZ Swagg Sauce LLC and Electric Smoke Vapor House have listed a combined total of approximately 10,000 products with the FDA. Neither company submitted a premarket application for its nontobacco nicotine products.
The FDA also said it is processing applications for approximately 1 million other products submitted by more than 200 manufacturers. The agency did not address the most popular synthetic tobacco product on the market, the disposable vape Puff Bar.
The agency said it also issued 107 warning letters to retailers in the past two weeks for illegally selling nontobacco nicotine products, including certain e-cigarette or e-liquid products, to underage purchasers.
“FDA has been fully committed to actively implementing this critical new law regulating non-tobacco nicotine products since its passage, and the warning letters announced today are just the beginning of our compliance and enforcement actions” Brian King, director of the FDA’s Center for Tobacco Products, said in a statement.
But anti-tobacco advocates said the agency’s actions fell flat.
“All unauthorized synthetic nicotine products are now illegal and by law must be removed from the market now, not at some undetermined date in the future,” said Matt Myers, president of the Campaign for Tobacco-Free Kids.
“It is unacceptable that this deadline came and went on Wednesday with the FDA taking only minimal action to enforce a law the FDA itself sought from Congress … The FDA’s failure to fully enforce the law and clear all unauthorized products from the market is unacceptable. It ignores explicit deadlines set by Congress and puts America’s kids at risk,” Myers said.
In a letter sent to the FDA ahead of Wednesday’s deadline, Sens. Susan Collins (R-Maine) and Dick Durbin (D-Ill.) said they were concerned the agency wouldn’t meet the deadline, and called on Commissioner Robert Califf to pull from the market all products without an authorization.
Durbin and Collins were two of the key senators who spearheaded the effort to give the FDA the power to regulate synthetic nicotine.
“We are concerned that FDA is failing to implement the law, which has grave consequences for the health of children across America,” the senators wrote. “We fear FDA is stumbling down the same path that ignited the youth vaping epidemic in the first place.”
They noted that several e-cigarette manufacturers whose applications were subject to marketing denial orders attempted to circumvent the agency’s oversight by switching to synthetic nicotine.
In a speech on the Senate floor Wednesday, Durbin slammed the agency’s efforts at regulating tobacco and vaping products.
“The FDA is supposed to protect all Americans and particularly our children. I’m calling on FDA to finally come to its senses. Err on the side of public safety, on the side of kids, not tobacco companies. This free fall in the legal department at the FDA is unimaginable. It’s not safe for America. And it’s not safe for our future,” Durbin said.
The American Vapor Manufacturers group said Congress’s deadline was “impossible” for companies to meet.
“It should not be surprising that some companies could not submit the robust data and evidentiary requirements in time,” said Amanda Wheeler, the group’s president. “This latest crackdown shows that the FDA would rather pander to politicians who believe they know better than the millions of Americans who will now be forced back to cigarettes as more and more vaping products are banned.”
